US Stem Cell Inc (USRM)

[Dragon Lady]

REGEN trial, CEO DEFUNDED, PATIENT SAFETY CONCERNS:

Ever wonder why all the key "HEART TRIALS" including MARVEL and REGEN suddenly lost their "funding" in 2010, and were thus HALTED/SUSPENDED TO THIS DAY 2017 for supposed "LACK OF FUNDING", according to the most recent SEC 10-K, PAGE 23 among other pages, March 2017 filing?

It was then Bioheart CEO, Karl Groth PhD, HE DEFUNDED and HE SUSPENDED the trial and then yanked the funding on it, per his and the investor fund CONCERNS OVER “PATIENT SAFETY”. SHAZAM, imagine that?

JUST READ THIS "PR" as released in 2011, which explains in great detail that then CEO Karl Groth PhD (IMO, their most qualified and experienced CEO they ever had), who also was a member of the ASCENT FUND, a venture capital fund who had, PAST TENSE, had agreed to fund those key trials, how he and the fund "backed-out" due to BIOHEART FAILING TO ADDRESS PATIENT SAFETY CONCERNS IN SAID CLINICAL TRIAL, the key REGEN TRIAL, that never, ever actually happened, and still hasn't happened to this day in mid 2017, SEVEN DAMN YEARS LATER, LOL !

It wasn't LACK OF FUNDING per say then, it was that the "big money guys" PULLED THE DAMN PLUG, as they were afraid of Bioheart failing to ADDRESS PATIENT SAFETY ISSUES seen in the earlier trials (irregular heart beats, 6 patient deaths according to the 2014 SEC filed 10-K, etc):

http://www.bizjournals.com/southflorida/news/2011/01/03/bioheart-suspends-clinical-trial.html


QUOTE:

"Bioheart suspends clinical trial
Jan 3, 2011, 11:01am EST

Bioheart has suspended its clinical trial for cardiac patients after a dispute with the group providing it with funding.

The Sunrise-based company (OTCBB: BHRT) started work on the Regen trial in February. It was designed as a Phase I safety study for Bioheart’s MyoCell, a stem cell treatment for cardiac patients.

Bioheart signed an agreement with Ascent Medical Product Development Centre, an affiliate of Ascent Private Equity, to oversee and conduct the trial. At the time, Ascent Private Equity leaders Karl E. Groth and Peggy Farley were directors of Bioheart, and CEO and COO, respectively.

Bioheart's Chief Scientific Officer Kristin Comella said this only impacts the Regen trial they hoped to conduct in Jordan, where they couldn't secure governmental approval. The company still plans to conduct the Regen trial, or another clinical trial with MyoCell, in the U.S., but it needs more funding to do so, she added.

According to a Securities and Exchange Commission filing by Bioheart, patient enrollment in the Regen trial never began. The company received a letter from Ascent, terminating its agreement to oversee the trial and demanding payment for its services. The letter said Bioheart had not addressed patient safety concerns expressed by Ascent and had terminated its MyoCell manufacturing staff, making delivery of the product to patients unavailable.

However, Bioheart stated in its SEC filing that it disputes that Ascent has grounds for terminating the agreement and asking for compensation.

The disagreement between Bioheart and Ascent could explain why Groth and Farley resigned from Bioheart in November.

Bioheart shares closed Friday at 33 cents. The 52-week high was 94 cents on April 16. The 52-week low was 10 cents on Aug. 24."

END OF PR news release.

GROTH as CEO not only pulled the funding per the ASCENT venture fund, he then quit as the damn CEO , then resigned and quit the company Bioheart entirely, and walked away from the whole mess.

THIS...THIS, this "technology" is now what's gonna get RMAT "approval" supposedly? I just find a lot, a lot of "problems" if you ask me. Holes so big, you can drive a Mac Truck through um, worse than Swiss Cheese if you ask me for my 2-bit opinion on it.

Again, how the hell would the FDA reviewers now already know all this history of these "HEART TRIALS", including the SERIOUS ADVERSE EVENTS in the older SEC filings, and why the REGEN trial got defunded for "PATIENT SAFETY CONCERNS" by their key funding source and the CEO of Bioheart at the time even freaking was involved in "PULLING THE PLUG" to defund that key "HEART" clinical trial, and he states it was for "FAILURE TO PROPERLY ADDRESS PATIENT SAFETY CONCERNS", etc? How is that possible?

https://www.sec.gov/Archives/edgar/data/1388319/000114544314000356/d31044-10k.htm

SEC 10-K, PAGE 31:

"Our product candidates may never be commercialized due to unacceptable side effects and increased mortality that may be associated with such product candidates.

Possible side effects of our product candidates may be serious and life-threatening. A number of participants in our clinical trials of MyoCell have experienced serious adverse events potentially attributable to MyoCell, including six patient deaths and 18 patients experiencing irregular heartbeats. A serious adverse event is generally an event that results in significant medical consequences, such as hospitalization, disability or death, and must be reported to the FDA. The occurrence of any unacceptable serious adverse events during or after preclinical and clinical testing of our product candidates could temporarily delay or negate the possibility of regulatory approval of our product candidates and adversely affect our business. Both our trials and independent trials have reported the occurrence of irregular heartbeats in treated patients, a significant risk to patient safety. We and our competitors have also, at times, suspended trials studying the effects of myoblasts, at least temporarily, to assess the risk of irregular heartbeats, and it has been reported that one of our competitors studying the effect of myoblast implantation prematurely discontinued a study because of the high incidence of irregular heartbeats. While we believe irregular heartbeats may be manageable with the use of certain prophylactic measures including an ICD, and antiarrhythmic drug therapy, these risk management techniques may not prove to sufficiently reduce the risk of unacceptable side effects.

Although our early results suggest that patients treated with MyoCell do not face materially different health risks than heart failure patients with similar levels of damage to the heart who have not been treated with MyoCell, we are still in the process of seeking to demonstrate that our product candidates do not pose unacceptable health risks. We have not yet treated a sufficient number of patients to allow us to make a determination that serious unintended consequences will not occur."

Again, just to me, how the hell would the FDA RMAT people and whoever else not know this sh@t and all this Bioheart history, why their key trials were defunded and never progressed any further in 2010, etc? It seems impossible to me, that the FDA is not gonna uncover or already know all these major red flag problems Bioheart had during these trials, their key trials that never came close to reaching conclusion, stopped in 2010, and never re-started again.

MAKES NO FREAKING SENSE TO ME? Their OWN CEO Karl Groth PhD, HE, HE PULLED THE FUNDING ON PERHAPS THEIR MOST CRITICAL CLINICAL TRIAL- and that trial was NEVER, EVER, EVER, EVER funded or restarted again since 2009/2010, AT LEAST SEVEN DAMN YEARS LATER TO THIS DAY. REGEN is still sitting "suspended" and UNFUNDED, gone and going NOWHERE? WHY? WHY WOULD THAT BE? WHY? WHY? HOW DOES THAT MAKE SENSE? WHY?????